With the evolution of the Experimental Therapeutics Clinical Trials Network (ETCTN), the Johns Hopkins Translational Science Team (JHTST) expanded in 2016 by bringing 5 (now 6) Affiliate Organizations (AO) under our Lead Academic Organization (LAO) with the goal to enhance and accelerate our collective contribution to the drug development efforts of the NCI. We have organized a comprehensive and cohesive infrastructure that can conduct high-quality clinical trials evaluating novel anticancer agents, in combinations, in molecularly selected patient populations, or rare tumor sites. Our infrastructure stems from the need to be clinically efficient, regulatory compliant and scientifically rigorous in our approach as we collaborate as network members within the ETCTN. Our infrastructure consists of seven experienced NCI-designated Cancer Centers: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Emory Winship Cancer Institute, Georgetown Lombardi Comprehensive Cancer Center, Sidney Kimmel Cancer Center at Thomas Jefferson University, Memorial Sloan Kettering Cancer Center, University of Virginia Cancer Center, and University of Wisconsin Carbone Cancer Center. This collection of Centers brings together many unique discovery strengths, diverse patient volumes, and locations both urban and rural. We will focus on 4 Specific Aims:
Aim 1 - To lead and maintain a clinical trial consortium that will support cancer clinical trials from Phase 1 initiation through proof-of- activity and foster seamless Phase 2 clinical development of NCI CTEP IND agents;
Aim 2 - To actively participate and engage disease-focused clinical investigators in the ETCTN by promoting accrual to a range of ETCTN studies led by other LAO/AO members;
Aim 3 - To incorporate and implement innovative correlative and biological laboratory studies in the context of or as eligibility for participation in early phase clinical studies that enhance our understanding of determinants of toxicity and response that will be used for further definitive practice-changing clinical trial evaluation;
and Aim 4 - To train the next generation of investigators in drug development. With 7 Centers within our Consortium, we anticipate no problem in meeting the grant metrics of 100 accruals per year, submitting enough LOI concepts to have 6 new studies approved each year, functioning as a network by having Disease-Focused Clinical Investigators champion ETCTN studies at each Site across disease sites, and to provide opportunities to engage and train early career investigators in drug development. We anticipate that our contributions within the ETCTN will impact the clinical care of cancer patients.

Public Health Relevance

Our Consortium will continue its long- standing contribution to the drug development efforts of the NCI by leveraging its collective experience, commitment to collaboration, and legacy of training young investigators to impact the clinical care of cancer patients. We promote inclusiveness of the many medical disciplines that are required to conduct innovative, informative, and insightful early phase clinical trials. We anticipate enhanced interactions with the National Clinical Trials Network to bring forward successes from the efforts of the ETCTN.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZCA1)
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Ivy, S Percy
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Johns Hopkins University
Internal Medicine/Medicine
Schools of Medicine
United States
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Levis, Mark J; Perl, Alexander E; Altman, Jessica K et al. (2018) A next-generation sequencing-based assay for minimal residual disease assessment in AML patients with FLT3-ITD mutations. Blood Adv 2:825-831
Liu, Tao; Ivaturi, Vijay; Sabato, Philip et al. (2018) Sorafenib Dose Recommendation in Acute Myeloid Leukemia Based on Exposure-FLT3 Relationship. Clin Transl Sci 11:435-443
Pietanza, M Catherine; Waqar, Saiama N; Krug, Lee M et al. (2018) Randomized, Double-Blind, Phase II Study of Temozolomide in Combination With Either Veliparib or Placebo in Patients With Relapsed-Sensitive or Refractory Small-Cell Lung Cancer. J Clin Oncol 36:2386-2394
Yeruva, Sri Lakshmi Hyndavi; Zhao, Fengmin; Miller, Kathy D et al. (2018) E2112: randomized phase iii trial of endocrine therapy plus entinostat/placebo in patients with hormone receptor-positive advanced breast cancer. NPJ Breast Cancer 4:1
Uldrick, Thomas S; Ison, Gwynn; Rudek, Michelle A et al. (2017) Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research HIV Working Group. J Clin Oncol 35:3774-3780
Day, Daphne; Monjazeb, Arta M; Sharon, Elad et al. (2017) From Famine to Feast: Developing Early-Phase Combination Immunotherapy Trials Wisely. Clin Cancer Res 23:4980-4991
Pili, Roberto; Quinn, David I; Hammers, Hans J et al. (2017) Immunomodulation by Entinostat in Renal Cell Carcinoma Patients Receiving High-Dose Interleukin 2: A Multicenter, Single-Arm, Phase I/II Trial (NCI-CTEP#7870). Clin Cancer Res 23:7199-7208
Weber, Jeffrey S; Levit, Laura A; Adamson, Peter C et al. (2017) Reaffirming and Clarifying the American Society of Clinical Oncology's Policy Statement on the Critical Role of Phase I Trials in Cancer Research and Treatment. J Clin Oncol 35:139-140
Connolly, Roisin M; Li, Huili; Jankowitz, Rachel C et al. (2017) Combination Epigenetic Therapy in Advanced Breast Cancer with 5-Azacitidine and Entinostat: A Phase II National Cancer Institute/Stand Up to Cancer Study. Clin Cancer Res 23:2691-2701
Mehrotra, Shailly; Gopalakrishnan, Mathangi; Gobburu, Jogarao et al. (2017) Population pharmacokinetics and site of action exposures of veliparib with topotecan plus carboplatin in patients with haematological malignancies. Br J Clin Pharmacol 83:1688-1700

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